【目的】观察参蛤散治疗心肾阳虚型射血分数保留心力衰竭（HFpEF）合并心房颤动（简称房颤）的有效性及安全性。 【方法】将2024 年6 月至2025 年7 月在上海中医药大学附属龙华医院心病科就诊的80 例心肾阳虚型HFpEF 合并房颤的患者 按随机数字表法随机分为治疗组和对照组，每组各40 例。对照组给予遵循指南的规范化治疗，治疗组在对照组的基础上加 用参蛤散颗粒治疗，2 组疗程均为12 周。观察2 组患者治疗前后血清N 末端B 型利钠肽原（NT-proBNP）、左室射血分数 （LVEF）、无氧阈氧耗量（VO2 AT）、峰值氧耗量（VO2 peak）、明尼苏达心力衰竭生活质量量表（MLHFQ）评分和6 min 步行试 验（6MWT）距离的变化情况，并评价2 组患者的中医证候疗效和用药安全性。【结果】（1）疗效方面，治疗12 周后，治疗组的 总有效率为95.00%（38/40），对照组为77.50%（31/40），组间比较（χ2 检验），治疗组的中医证候疗效明显优于对照组（P＜ 0.05）。（2）血清NT-proBNP 水平及LVEF 方面，治疗后，2 组患者的血清NT-proBNP 水平均较治疗前下降（P＜0.01），LVEF 值 均较治疗前升高（P＜0.01），且治疗组对血清NT-proBNP 水平的下降幅度及对LVEF 值的升高幅度均明显优于对照组（P＜ 0.01）。（3）心肺运动试验方面，治疗后，2 组患者的VO2 AT、VO2 peak 水平均较治疗前升高（P＜0.01），且治疗组对VO2 AT 和 VO2 peak 水平的升高幅度均明显优于对照组（P＜0.01）。（4）生活质量与运动耐力方面，治疗后，2 组患者的MLHFQ 评分均较 治疗前下降（P＜0.01），6MWT 距离均较治疗前升高（P＜0.01），且治疗组对MLHFQ 评分的下降幅度及对6MWT 距离的升高 幅度均明显优于对照组（P＜0.01）。（5）安全性方面，治疗期间，2 组患者均未出现恶心、呕吐、过敏等药物不良反应，且2 组 患者治疗前后的血、尿常规及肝、肾功能等安全性指标均未见异常变化。【结论】参蛤散治疗心肾阳虚型HFpEF 合并房颤患 者具有良好的有效性及安全性，能有效降低血清NT-proBNP 水平，提高患者LVEF 值，改善患者心功能，提高患者生活质量。

Objective To observe the efficacy and safety of Shen’ge San in treating patients with heart failure with preserved ejection fraction（HFpEF）complicated by atrial fibrillation（AF）and presenting with heart-kidney yang deficiency syndrome. Methods Eighty patients with HFpEF complicated by AF and heart-kidney yang deficiency syndrome who attended the Department of Cardiology，Longhua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine from June 2024 to July 2025 were randomly assigned to a treatment group and a control group using a random number table，with 40 cases in each group. The control group received guideline directed standardized treatment，while the treatment group received Shen’ge San granules in addition to the treatment given to the control group. The treatment course for both groups was 12 weeks. The changes in serum N terminal pro-B-type natriuretic peptide（NT-proBNP），left ventricular ejection fraction（LVEF），oxygen uptake at anaerobic threshold（VO2 AT），peak oxygen uptake（VO2 peak），Minnesota Living with Heart Failure Questionnaire（MLHFQ）score，and 6-minute walk test（6MWT）distance were observed before and after treatment in both groups. The traditional Chinese medicine（TCM）syndrome efficacy and medication safety were evaluated in both groups. Results（1）Regarding efficacy，after 12 weeks of treatment，the total effective rate was 95.00%（38/40）in the treatment group and 77.50%（31/40）in the control group；intergroup comparison（by chi square test）showed that the TCM syndrome efficacy in the treatment group was significantly superior to that in the control group（P＜0.05）.（2）Regarding serum NT-proBNP level and LVEF，after treatment，serum NT-proBNP levels in both groups decreased compared with those before treatment（P＜0.01），and LVEF values increased compared with those before treatment（P＜0.01）. The treatment group showed significantly greater reductions in serum NT-proBNP level and increases in LVEF value compared with the control group（P＜0.01）.（3）Regarding cardiopulmonary exercise testing，after treatment，VO2 AT and VO2 peak levels in both groups increased compared with those before treatment（P＜0.01），and the treatment group showed significantly greater increases in both VO2 AT and VO2 peak levels compared with the control group（P＜0.01）.（4）Regarding quality of life and exercise tolerance，after treatment，MLHFQ scores in both groups decreased compared with those before treatment（P＜0.01），and 6MWT distances increased compared with those before treatment（P＜0.01）. The treatment group showed significantly greater reductions in MLHFQ score and increases in 6MWT distance compared with the control group（P＜0.01）.（5）Regarding safety，during the treatment period，no adverse drug reactions such as nausea，vomiting，or allergy occurred in either group，and no abnormal changes were observed in safety indicators including blood and urine routine tests and liver and kidney function before and after treatment in both groups. Conclusion Shen’ge San demonstrates good efficacy and safety in treating patients with HFpEF complicated by AF and heart-kidney yang deficiency syndrome. It is effective on decreasing serum NT-proBNP levels，improving LVEF，enhancing cardiac function，and increasing quality of life in these patients.

R259.416

国家科技重大专项（编号：2025ZD0548304）；上海市卫生健康委员会科研项目（编号：202040341）；上海市促进市级医院临床 技能与临床创新三年行动计划资助项目（编号：SHDC2020CR4097）